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Interpreting adverse drug reaction (ADR) reports as hospital patient safety incidents

Emma C Davies1, Christopher F Green, David R Mottram

  • 1The Royal Liverpool and Broadgreen University Hospitals Trust, Prescot Street, Liverpool L7 8XP, UK. edavies@liverpool.ac.uk

British Journal of Clinical Pharmacology
|July 21, 2010
PubMed
Abstract

Insights

Adverse drug reactions (ADRs) assessed by NPSA criteria showed most were moderate risk. However, NPSA classification offers limited extra patient safety value beyond the established MHRA Yellow Card Scheme.

Area of Science:

  • Pharmacovigilance
  • Patient Safety
  • Drug Safety Monitoring

Background:

  • Adverse drug reactions (ADRs) are a reporting category within the UK's National Patient Safety Agency (NPSA) system.
  • The Medicines and Healthcare Products Regulatory Agency (MHRA) pharmacovigilance system, specifically the Yellow Card Scheme, is the primary method for collecting ADR data.

Purpose of the Study:

  • To assess ADRs using NPSA criteria in a UK inpatient setting.
  • To evaluate the implications of using NPSA criteria for ADR reporting and patient safety.

Main Methods:

  • A 6-month prospective study involving 3695 inpatient episodes.
  • Assessment of identified ADRs using NPSA tools, evaluating patient and organizational impact.

Main Results:

  • Out of 733 assessed ADRs, 73.3% were low impact, 24.7% moderate, 1.91% severe, and 0.14% catastrophic for patients.
  • Less than 2% of ADRs met NPSA criteria for detailed analysis.
  • Significant ADRs were associated with bleeding, renal impairment, and Clostridium difficile infection.

Conclusions:

  • Classification of ADRs using NPSA guidance provides minimal additional benefit compared to the MHRA Yellow Card Scheme.
  • The existence of multiple reporting systems may confuse healthcare professionals and hinder patient safety efforts.
  • A unified reporting message is recommended to improve ADR data collection and patient safety.

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